VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY (SALICYLIC ACID) SPRAY [JF LABS, INC.]

VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY (SALICYLIC ACID) SPRAY [JF LABS, INC.]
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NDC 49681-002-05
Set ID 2ea0ccef-2f41-813b-6fe3-d695fc8775eb
Category HUMAN OTC DRUG LABEL
Packager JF Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART358
  • Drug Facts

    Active IngredientPurpose
    1.8% Salicylic AcidAnti-dandruff, anti seborrheic dermatitis, anti-psoriasis
  • USE

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

  • WARNINGS SECTION

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

    Flammable.  Keep away from heat and open flame.

    For external use only

    Ask a physician before use it you have a condition that covers a large area of your body.

    Avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

    If condition worsens or does not improve, after regular use of this product as directed, consult a physician.

  • DOSAGE AND ADMINISTRATION SECTION

    Directions:  Hold bottle 6 inches away from hair and spray evenly.  Massage into hair and scalp and style.  For curly hair and braids, use daily.  On relaxed hair use before drying.

    Other Information:  Store away from direct sunlight.

  • INACTIVE INGREDIENT SECTION

    Inactive ingedients:  Water(Aqua), SD Alcohol 40B, Propylene Glycol, Cyclo-pentasiloxane, Isopropyl Palmitate, Phenyl Trimethicone, Sodium Citrate, Sodium Hydroxide, PPG-5 Ceteth-20, Olea Europaea (Olive) Oil, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Camphor, Menthol, Cetrimonium Chloride, Sulfur, Polysorbate-20, Methylparaben, Propylparaben, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitmin A), Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Pinus Sylvestris Leaf Extract, Humulus Lupulus (Hops) Extract, Citrus Limonum (Lemon) Peel Extract, Fragrance (Parfum) 

  •  

    Vitale 12 in 1 Spray Label

    AFAM CONCEPT, INC.
    Chicago, IL 60629

    LONDON NW 10 6JH, UK

    www.vitaleproducts.com 
    (773)838-1336, (800) 262-2326

    Registered # 1,387,930

  • INGREDIENTS AND APPEARANCE
    VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY  
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Camphor (UNII: 5TJD82A1ET)  
    Menthol (UNII: L7T10EIP3A)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Sulfur (UNII: 70FD1KFU70)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Alpha-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Equisetum Arvense Extract (UNII: 1L0VKZ185E)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-002-05237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35811/01/2009
    Labeler - JF Labs, Inc. (047821728)
    Registrant - JF Labs, Inc. (047821728)
    Establishment
    NameAddressID/FEIBusiness Operations
    Afam Concept, Inc.103330098MANUFACTURE

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